Pharma: Socializing in a Straightjacket

At first glance, the Facebook fan page for Epilepsy Advocate is like many others, with regular updates, shared links and a small base of supporters.

But the page, launched in October, is different from most in two crucial respects: it doesn't allow comments or even the ability to "like" an item.

Welcome to the world of social media for regulated industries like pharmaceuticals. The Epilepsy Advocate is a so-called unbranded community run by pharma company UCB, maker of epilepsy treatments. As a drugmaker, UCB has to take a cautious line with its social Web efforts for fear of running afoul of rules set for all pharmaceutical advertising by the Food and Drug Administration that often make what's allowed or not rather murky.

While UCB isn't mentioned on the site, the company still has obligations under the FDA regulations. For instance, if a user reported an adverse reaction to its treatment there, UCB would need to report it to the FDA. What's more, pharma companies can be held liable by regulators for people discussing off-label use of their products on their sites. That means the dynamic back and-forth of social media ends up getting replaced by a particularly static experience.

"The concept and value of the social medium as this unconstrained exchange is not consistent with the regulatory constraints," said Chris Kuenne, CEO of Rosetta, which built the Epilepsy Facebook page for UCB.

It is a common feature of many pharma-related Web sites that the key social features, like commenting, are turned off. Nexium, a drug from AstraZeneca, has a Facebook page that won't let visitors post to its wall, comment on its posts or share them. Yet the drugmaker does take a step towards social with a heavily monitored social area. All posts are moderated before they're posted to the site. The restrictions make the page a mostly one-way communications channel with only a handful of posts from consumers, and several discussion topics without any consumer input at all.

"One mistake can mean the FDA forcing the pharma company to take the drug off the market," said Shiv Singh, social media lead at Razorfish. "They're justifiably extra-cautious in this realm."

The gray areas that exist have led some pharma companies to shy away from the first tenet of social media marketing: listening. Some choose to use online monitoring data at an aggregate level since they are required to report any adverse conditions they come across. Jeremiah Owyang, partner at social media consultancy Altimeter Group, said that's even led to drug companies blocking employees from visiting social sites out of fear they'll come across a report of an adverse reaction.

Those fears might be unfounded. A report by Nielsen, parent company of Adweek, found that only one in 500 healthcare related messages met the four FDA requirements for reporting an adverse event: 1) an identifiable patient; 2) an identifiable reporter; 3) a specific drug; and 4) an adverse event. Still, the FDA does not have regulations specifically designed for online discussions. For instance, the current rules require reporting if there is an "identifiable reporter." Since many posters use Web pseudonyms, this would probably knock out most messages, but what's the expectation on the pharma company to track down the reporter's real identity?

"The challenge is an internal problem," said William Martino, vp of digital strategy at Saatchi Wellness. "It's a manpower problem. They may not be staffed for it. In an online world people expect immediate feedback."

The issue is pressing enough that the FDA last month held two days of hearings on pharma marketing in social media. The FDA did not offer additional guidance at the meeting, according to participants.

The larger problem of the regulations, said Kuenne, is regulations add costs, particularly in manpower, that make social programs bad investments. For instance, social media updates can sometimes need to get approval from a company's medical-legal regulatory departments.

"Rule No. 1 of what's becoming the 2.0 version of social marketing is having a much more rigorous view of what's the economic benefit to the brand" of programs, he said.

The other big hurdle regulations have placed on pharma marketers is they've exacerbated a tendency of the industry to lag behind the overall marketing industry in adapting new tactics. Digitas is helping clients by creating "social playbooks" that they can use to design their approach to the new channels, said Bruce Grant, svp, business strategy for Digitas Health.

"In our experience, much of the hesitancy in the regulated healthcare industry is the same hesitancy we saw in other industries of how to engage in a medium that marketers can't control," he said.